Content analysis
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Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. freshman Good
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New words:
aggregate, apparent, arrangement, assembly, caution, close, commonly, consolidated, constant, constitute, contingent, declared, deem, dioxide, disclaim, discretion, earlier, Electrocardiogram, emergency, foreseeable, Gathering, geopolitical, GPO, greatest, harbor, individually, knowledge, labor, lead, leakage, lengthening, level, light, lingering, Litigation, negotiate, oxygen, pandemic, par, participating, payment, personnel, policy, prosecute, pursue, readily, regular, Retrieval, revise, saturation, scientific, Section, set, shipping, similar, social, speak, spending, suggested, technology, theft, unauthorized, undue, upcoming, volume, warehouse, weakening, website
Removed:
accuracy, achievement, caption, collection, comparable, comprehensive, conformity, continue, correspondingly, decrease, denominated, detail, Dollar, doubtful, entitled, environment, establish, evaluating, event, experienced, forecast, harm, hereof, integrated, Japanese, lab, lower, mentioned, mix, occurrence, predicted, project, rapidly, recognition, relate, reliable, revaluing, review, strength, substantial, terminology, transaction, uniformly, valuation, variance, yen
Financial report summary
?Risks
- Our financial performance is significantly dependent on a limited number of products, and disruptions in our ability to sell these products may have a material adverse effect on our business.
- We have significant international sales as well as international supply chain links and we face risks related to health epidemics that could adversely affect our revenue.
- Our continued success depends on the integrity of our supply chain, including multiple single-source suppliers, the disruption of which could negatively impact our business.
- We rely on third-party suppliers for certain of our raw materials and components.
- We have been subject to securities class action litigation and derivative litigation, and we may be subject to similar or other litigation in the future.
- There is no assurance that our internal and external sources of liquidity will at all times be sufficient for our cash requirements.
- The manufacture of our products requires strict adherence to regulatory requirements governing medical devices and if we or our suppliers encounter problems our business could suffer.
- Our markets are very competitive, and we sell certain of our products in a mature market.
- We manufacture and store our products at a single facility in Florida.
- Our inability to collect on our accounts receivables from customers may have an adverse effect on our business operations and financial condition.
- If we fail to maintain relationships with Integrated Delivery Networks and Group Purchasing Organizations, sales of our products could decline.
- Cost-containment efforts of our customers and purchasing groups could adversely affect our sales and profitability.
- Any failure in our efforts to access and educate clinicians, anesthesiologists, radiologists, and hospital administrators regarding the advantages of our products could significantly limit our product sales.
- The lengthy sales cycle for medical devices could delay our sales.
- Because we rely on distributors to sell our products outside of the U.S., our revenues could decline if our existing distributors do not continue to purchase products from us or if our relationship with any of these distributors is terminated.
- If we do not successfully develop and commercialize enhanced products or new products that remain competitive, we could lose revenue opportunities and customers, and our ability to achieve growth would be impaired.
- We are highly dependent on our founder, Chairman, President and Chief Executive Officer, Roger Susi.
- If we fail to attract and retain the talent required for our business, our business could be materially harmed.
- We may be unable to scale our operations successfully.
- We engage in related party transactions, which result in a conflict of interest involving our management.
- Any acquisitions of technologies, products, and businesses may be difficult to integrate, could adversely affect our relationships with key customers, and/or could result in significant charges to earnings.
- The environment in which we operate makes it difficult to accurately forecast our business performance.
- There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with GAAP. Furthermore, portions of GAAP require the use of fair value models which are variable in application and methodology from appraiser to appraiser. Any changes in estimates, judgments and assumptions used could have a material adverse effect on our business, financial position, and operating results.
- Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results.
- We are subject to various privacy and consumer protection laws.
- We are subject to substantial government regulation that is subject to change and could force us to make modifications to how we develop, manufacture, market, and price our products.
- If we fail to obtain, or experience significant delays in obtaining, FDA clearances or other necessary approvals to commercially distribute new products, our ability to maintain profitability or grow will suffer.
- We are subject to risks associated with doing business outside of the U.S.
- We may incur product liability losses or become subject to other lawsuits related to our products, business, and insurance coverage could be inadequate or unavailable to cover these losses.
- Defects or failures associated with our products and/or our quality control systems could lead to the filing of adverse event reports, recalls or safety alerts and negative publicity and could subject us to regulatory actions.
- Our products or product types, or MR imaging could be subject to negative publicity, which could have a material adverse effect on our financial position and results of operations and could cause the market value of our common stock to decline.
- U.S. healthcare policy and changes thereto, including the Patient Protection and Affordable Care Act, may have a material adverse effect on our financial condition and results of operations.
- We are subject to healthcare fraud and abuse regulations that could result in significant liability, require us to change our business practices and restrict our operations in the future.
- We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.
- We and our suppliers and customers are required to obtain regulatory approvals to comply with regulations applicable to medical devices, including infusion pumps, and these approvals could result in delays or increased costs in developing new products.
- We and our suppliers and customers are required to maintain compliance with regulations applicable to medical devices, including infusion pumps, and it could be costly to comply with these regulations and to develop compliant products and processes. Failure to comply with these regulations could subject us to sanctions and could adversely affect our business.
- Our operations are subject to environmental laws and regulations, with which compliance is costly and which exposes us to penalties for non-compliance.
- Our success depends on our ability to protect our intellectual property.
- Our unpatented trade secrets, know-how, confidential and proprietary information, and technology may be inadequately protected.
- There can be no assurance of timely patent review and approval to minimize competition and generate sufficient revenues.
- We may become involved in patent litigation or other intellectual property proceedings relating to our current and future product clearances, which could result in liability for damages or delay or stop our development and commercialization efforts.
- We may be subject to claims that we, our board members, employees, or consultants have used or disclosed alleged trade secrets or other proprietary information belonging to third parties and any such individuals who are currently affiliated with one of our competitors may disclose our proprietary technology or information.
- Our common stock price has been and will likely continue to be subject to significant fluctuations and volatility, and you may be unable to sell your shares at a fair price, or at all.
- Any use of capital to repurchase shares of our common stock, or the election to continue to pay a regular cash dividend, could have a material adverse effect on our stock price and our business.
- We may need or choose to raise additional capital in the future, which could result in dilution to our stockholders and adversely affect stock price.
- Roger Susi, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, owns a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
- The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.
- As a result of being a public company, we are obligated to establish and maintain adequate internal controls. Failure to develop and maintain adequate internal controls or to implement new or improved controls could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
- Our business practices are more visible as a public company, and this could impact our competitive environment and our risk of potential litigation.
- We may and have become involved in securities class action litigation that could divert management’s attention from our business and adversely affect our business and could subject us to significant liabilities.
- If securities or industry analysts fail to initiate research coverage of our stock, downgrade our stock, or discontinue coverage, our trading volume might be reduced, and our stock price could decline.
- Our charter documents and Delaware law have provisions that may discourage an acquisition of us by others and may prevent attempts by our stockholders to replace or remove our current management.
Management Discussion
- ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
- You should read this discussion and analysis together with our audited financial statements, the notes to such statements and the other financial information included in this Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth under the section entitled “Risk Factors” and elsewhere in this Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements. See “CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS” for a discussion of the uncertainties, risks and assumptions associated with these statements.
- We develop, manufacture, market and distribute Magnetic Resonance Imaging (“MRI”) compatible medical devices and accessories, disposables and services relating to them.